FORTIFICATION of Cereal-BASED BEVERAGES

10-05

7 December 2005

FINAL ASSESSMENT REPORT

APPLICATION A500

FORTIFICATION OF cEREAL-BASED BEVERAGES

FOOD STANDARDS AUSTRALIA NEW ZEALAND (FSANZ)

FSANZ’s role is to protect the health and safety of people in Australia and New Zealand through the maintenance of a safe food supply. FSANZ is a partnership between ten Governments: the Australian Government; Australian States and Territories; and New Zealand. It is a statutory authority under Commonwealth law and is an independent, expert body.

FSANZ is responsible for developing, varying and reviewing standards and for developing codes of conduct with industry for food available in Australia and New Zealand covering labelling, composition and contaminants. In Australia, FSANZ also develops food standards for food safety, maximum residue limits, primary production and processing and a range of other functions including the coordination of national food surveillance and recall systems, conducting research and assessing policies about imported food.

The FSANZ Board approves new standards or variations to food standards in accordance with policy guidelines set by the Australia and New Zealand Food Regulation Ministerial Council (Ministerial Council) made up of Australian Government, State and Territory and New Zealand Health Ministers as lead Ministers, with representation from other portfolios. Approved standards are then notified to the Ministerial Council. The Ministerial Council may then request that FSANZ review a proposed or existing standard. If the Ministerial Council does not request that FSANZ review the draft standard, or amends a draft standard, the standard is adopted by reference under the food laws of the Australian Government, States, Territories and New Zealand. The Ministerial Council can, independently of a notification from FSANZ, request that FSANZ review a standard.

The process for amending the Australia New Zealand Food Standards Code is prescribed in the Food Standards Australia New Zealand Act1991 (FSANZ Act). The diagram below represents the different stages in the process including when periods of public consultation occur. This process varies for matters that are urgent or minor in significance or complexity.

Final Assessment Stage

FSANZ has now completed two stages of the assessment process and held two rounds of public consultation as part of its assessment of this Application. This Final Assessment Report and its recommendations have been approved by the FSANZ Board and notified to the Ministerial Council.

If the Ministerial Council does not request FSANZ to review the draft amendments to the Code, an amendment to theCode is published in the Commonwealth Gazette and the New Zealand Gazette and adopted by reference and without amendment under Australian State and Territory food law.

In New Zealand, the New Zealand Minister of Health gazettes the food standard under the New Zealand Food Act. Following gazettal, the standard takes effect 28 days later.

Further Information

Further information on this Application and the assessment process should be addressed to the FSANZ Standards Management Officer at one of the following addresses:

Food Standards Australia New Zealand Food Standards Australia New Zealand

PO Box 7186PO Box 10559

Canberra BC ACT 2610The Terrace WELLINGTON 6036

AUSTRALIANEW ZEALAND

Tel (02) 6271 2222Tel (04) 473 9942

Assessment reports are available for viewing and downloading from the FSANZ website or alternatively paper copies of reports can be requested from FSANZ’s Information Officer at including other general inquiries and requests for information.

CONTENTS

Executive Summary and Statement of Reasons

Regulatory Problem

Objectives

Risk Assessment

Risk Management

Regulatory Options and Impact Analysis

Consultation

Conclusion and Statement of Reasons

1.Introduction

1.1Nature of Application

2.Regulatory Problem

3.Objectives

4.Background

4.1Current Regulation

4.2Ministerial Policy Guidance

4.3International Regulations

4.4Current Market

4.5Cereal-Based Beverages as a Substitute Food for Cows’ Milk

5.Relevant Issues

5.1Risk Assessment

5.2Risk Management

6.Regulatory Options

7.Impact Analysis

7.1Affected Parties

7.2Cost Benefit Analysis

8.Consultation

8.1Public Consultation

8.3World Trade Organization (WTO)

9.Conclusion and Recommendations

10.Implementation and Review

Attachment 1 - Draft Variations to the Australia New Zealand Food Standards Code....

Attachment 2 - Nutrition Assessment Report

Attachment 3 - Dietary Modelling Methodology Report

Attachment 4 - Summary of Submissions

Executive Summary and Statement of Reasons

Food Standards Australia New Zealand (FSANZ) received an Application from SoNatural Foods Australia (the Applicant) on 2 May 2003 seeking to amend Standard 1.3.2 – Vitamins and Minerals of the Australia New ZealandFood Standards Code (the Code), to permit the addition of calcium to cereal-based beverages (e.g. rice and oat beverages) at a maximum claim level of 240 mg (30% Recommended Dietary Intake (RDI)) per 200 mL reference quantity.

This Final Assessment Report discusses issues involved with this Application, including issues raised in submissions in response to the Draft Assessment, and recommends variations to the Code as at Attachment 1.

Regulatory Problem

The Applicant is seeking permission for the voluntary addition of calcium to cereal-based beverages. The Applicant states the purpose of their request is to provide a suitably nutritious milk alternative for consumers who are allergic/intolerant to dairy and/or soy foods or those who choose not to consume dairy products for health or philosophical reasons.

Currently, the Code permits the voluntary addition of calcium, in addition to other vitamins and minerals, to certain foods such as breakfast cereals, most dairy products, and soy-based analogues of dairy products, such as soy beverages and soy yoghurts; however, there is no permission for the voluntary addition (i.e. fortification) of calcium to cereal-based beverages. However, calcium compounds are currently added to some cereal-based beverages as food additives. Although added for technological function, they contribute towards the calcium content of the beverage, which may result in a content claim. These claims inform consumers of the presence of calcium in cereal-based beverages, which to some consumers, may be important information and affect their purchase decision.

Fortified cereal-based beverages are permitted to be manufactured and/or sold in New Zealand. Although, no fortified cereal-based beverages are currently manufactured in New Zealand, fortified products are being imported into Australia via New Zealand by virtue of the Trans-Tasman Mutual Recognition Arrangement (TTMRA). Thus, an inequitable situation exists for Australian manufacturers/importers. Incorporating permissions for the addition of vitamins and minerals to cereal-based beverages in a joint standard would provide further consistency and equity between Australian and New Zealand food standards.

Objectives

The specific objectives for the assessment of this Application are to:

protect the public health and safety of cereal-based beverage consumers; and
ensure adequate information is provided to enable consumers to make informed choices.

Risk Assessment

FSANZ has undertaken a risk assessment involving several components to inform an overall assessment of risk. The risk assessment included a Nutrition Assessment and Dietary Intake Assessment, which are provided in full detail at Attachment 2. The methodology for the Dietary Intake Assessment is described in Attachment 3.

The overall conclusions from the risk assessment suggest that non-dairy consumers are at risk of inadequate intakes of a variety of vitamins and minerals for which dairy milk makes an important contribution to the diets of the general population, and that use of a fortified cereal-based beverage may aid in mitigating this risk. In addition, there is a low prevalence of protein inadequacy among young non-dairy consumers that increases with age. Although the data for young children does not suggest overtly compromised protein intake, low protein intake in young children has more adverse health consequences than low protein intake in adults, as protein is important for normal growth and development.

Risk Management

This Final Assessment Report considers a number of issues relevant to the regulation of both fortified and non-fortified cereal-based beverages including:

managing the identified public health and safety risks associated with cereal-based beverages, with respect to their lower protein, fat and micronutrient content compared with cows’ milk and soy beverages;
the feasibility of increasing the protein content of cereal-based beverages;
the efficacy of adding vitamins and minerals to cereal-based beverages; and
the requirement for mandatory advisory labelling.

Regulatory Options and Impact Analysis

There are three possible regulatory options proposed at Final Assessment for this Application. These are:

Option 1 – Maintenance of the status quo; or

Option 2 – Amend Standard 1.3.2 to permit the voluntary addition of calcium to cereal-based beverages equal to the level permitted for beverages derived from legumes (which is based on cows’ milk), in addition to the requirement for specific advisory labelling; or

Option 3 – Amend Standard 1.3.2 to permit the voluntary addition of selected vitamins and minerals including calcium to cereal-based beverages, being the same range and equal levels as permitted for beverages derived from legumes (which is based on cows’ milk), in addition to the requirement for specific advisory labelling.

Consultation

The Draft Assessment Report for this Application was released for public comment from

3 August to 14 September 2005. A total of twenty submissions were received, with eleven submissions from industry, six from government, two from public health and one from a consumer of cereal-based beverages.

Ten submitters supported Option 3 to amend Standard 1.3.2 to permit the addition of selected vitamins and minerals to cereal-based beverages, as permitted for beverages derived from legumes. Six others supported a modified Option 3, two dairy industry submitters supported maintaining the status quo, one industry submitter did not specify their preferred regulatory option, and the consumer submitter supported fortification of cereal-based beverages. A summary of submitter comments is at Attachment 4.

Targeted consultation on the recommended advisory statement was conducted at Final Assessment. Eight participants were consulted, involving four representatives from the respective Australian and New Zealand national allergy and vegetarian/vegan societies and four health professionals specialising in allergies and intolerances.

All participants agreed that cereal-based beverages should be required to carry an advisory statement on their label. However, there were divergent views on the content of the advisory statement, particularly regarding the level of detail that should be provided to consumers.

Conclusionand Statement of Reasons

Option 3 is the preferred regulatory option as it fulfils the specific objectives of this Application and when compared with Options 1 and 2 delivers greater net benefits to all affected parties. In the interest of protecting public health and safety, Option 3 provides consumers of cereal-based beverages with a more nutritionally equivalent substitute food for dairy milk and guidance on the appropriate use of these beverages through use of an advisory statement. In addition, this option may be advantageous for manufacturers, with respect to product development and market innovation. Therefore, FSANZ recommends the draft variations to the Code as detailed in Attachment 1 be approved for the following reasons:

the fortification of cereal-based beverages would assist in protecting the health and safety of cereal-based beverage consumers through:

-allowing the manufacture of more nutritionally equivalent substitutes for dairy milk and soy beverages; and

-a prescribed requirement for mandatory advisory labelling to reduce the risk of inappropriate use of cereal-based beverages, particularly in the diets of children under the age of five years;

is consistent with FSANZ’s statutory objectives including Ministerial policy guidance on voluntary fortification;
the fortification of cereal-based beverages does not raise any safety concerns for consumers of these beverages or the general population;
permission to fortify cereal-based beverages in a joint food standard provides uniform regulations for these beverages between Australia and New Zealand;

a joint food standard provides regulatory certainty for industry and government enforcement agencies; and
the regulation impact assessment concludes that the benefits from permitting the fortification of cereal-based beverages with selected vitamins and minerals outweigh any potential costs to affected parties.

Decision

It is recommended that:

Standard 1.3.2 be amended to permit cereal-based beverages containing no less than 0.3% protein derived from cereals to be fortified with selected vitamins and minerals, being the same range and equal levels as those permitted for beverages derived from legumes;
Standard 1.2.3 be amended to require cereal-based beverages containing no more than 2.5% fat and less than 3% protein, or less than 3% protein only to carry a mandatory advisory statement to the effect that the product is not suitable as a complete milk replacement for children under the age of five years; and
the existing advisory labelling requirement for low fat milks and beverages (no more than 2.5% fat), as per Standard 1.2.3, be extended to apply to all cereal-based beverages, including oat beverages, rather than rice beverages alone.

The recommended draft variations to the Code are at Attachment 1.

The Table below outlines the recommended permissions for cereal-based beverages, and the corresponding maximum claims and maximum permitted quantity allowed per 200 mL reference quantity for each vitamin and mineral.

Table: Recommended vitamin and mineral permissions for cereal-based beverages per 200 mL reference quantity

Vitamins and Minerals / Maximum Claim per Reference Quantity
(proportion RDI) / Maximum Permitted Quantity of Vitamin or Mineral per Reference Quantity
Vitamin A / 110 µg (15%) / 125 µg
Thiamin / no claim permitted / 0.10 mg
Riboflavin / 0.43 mg (25%)
Vitamin B6 / no claim permitted / 0.12 mg
Vitamin B12 / 0.8 µg (40%)
Vitamin D / 1.0 µg (10%) / 1.6 µg
Folate / no claim permitted / 12 µg
Calcium / 240 mg (30%)
Magnesium / no claim permitted / 22 mg
Phosphorus / 200 mg (20%)
Zinc / no claim permitted / 0.8 mg
Iodine / 15 µg (10%)

1.Introduction

Food Standards Australia New Zealand (FSANZ) received an Application from SoNatural Foods Australia (the Applicant) on 2 May 2003 seeking to amend Standard 1.3.2 – Vitamins and Minerals of the Code to permit the addition of calcium to cereal-based beverages (e.g. rice and oat beverages) at a maximum claim level of 240 mg (30% Recommended Dietary Intake (RDI)) per 200 mL reference quantity.

This Final Assessment Report discusses issues involved with this Application, including issues raised in submissions in response to the Draft Assessment, and recommends a variation to the Code as at Attachment 1.

1.1Nature of Application

1.1.1Basis of the Application

The Applicant requested an amendment to Standard 1.3.2 of the Code, to permit the addition of calcium to beverages derived from cereals. As cereal-based beverages are consumed as a substitute food for dairy milk[1] by a small subgroup of the population, the Applicant considers that enabling the addition of calcium to these beverages to an equivalent level as found in dairy milk would provide consumers with a more nutritionally similar alternative.

1.1.2Amendments to the Original Application

During assessment of this Application, it has been recommended that the scope of the original Application be extended. Permission for the addition of calcium alone to cereal-based beverages was originally requested. At Draft Assessment a third regulatory option was considered to permit the addition of selected vitamins and minerals including calcium to cereal-based beverages, as permitted under Standard 1.3.2 for beverages derived from legumes. The concept of permitting other vitamins and minerals in addition to calcium was raised in the Initial Assessment Report, and was supported by the majority of submitters at Draft Assessment. The Applicant supports this proposed third regulatory option.

As this third option was the preferred regulatory option at Draft Assessment, the name of the Application was amended accordingly to more accurately reflect the nature of this Application.

The original Application requested a minimum percent protein of 0.5%, whereby only those cereal-based beverages containing greater than 0.5% would be permitted to be fortified. Cereal-based beverages generally contain between 0.3-1.4% protein, noting that the Applicant’s rice beverage contains 0.6% protein. Therefore, a minimum percent protein of 0.3% is more inclusive of other brands and varieties of cereal-based beverages currently available. Consequently, the Applicant has amended their original Application from 0.5% to 0.3% minimum protein.

2.Regulatory Problem

3.Objectives

In developing or varying a food standard, FSANZ is required by its legislation to meet three primary objectives, which are set out in section 10 of the FSANZ Act. These are: